1. .Field of the Invention
The present invention relates to an anti-peptic ulcer composition.
2. Description of the Related Art
The causes of a peptic ulcer are generally considered to be an upset of the balance between an offense factor and a defense factor, on the basis of the theory of Shay and Sun (1963).
More specifically, this theory postulates that an ulcer will be formed when the balance between the offense factors acting on digestive mucosa to form an ulcer (acid, pepsin, etc.) and the defense factors having an anti-ulcer effect (mucus, mucosa, blood stream, prostaglandin, etc.) is upset and the offense factors become more preferential.
Accordingly, the anti-peptic ulcer therapeutical agents have been broadly classified into offense factor inhibitors and defense factor potentiators, in accordance with the above theory, and many drugs therefore have been developed and used.
As the offense factor inhibitors, histamine H.sub.2 receptor antagonists having a potent gastric acid secretion inhibiting activity are widely used, as represented by drugs such as Cimetidine, Lanitidine, and Phamotidine. Also, Omeplasol, which is a proton pump inhibitor having a more potent gastric acid secretion inhibiting activity, has been developed.
On the other hand, as the defense factor potentiators, Gefalnate and Squralfate, which burst, protect and remedy gastric mucosa, Aldioxa and Glycyrrhizin, which are granulation neoplastic promoters and Cetraxate and Sophalcon, which are minute circulation ameliorators, are known. Also, Misoprostol, which is a PGE.sub.1 preparation of prostaglandin (PG) derivatives physiologically active in the living body having cytoprotection, and Ornoprosteyl, which is a PGE.sub.2 preparation, are known.
Nevertheless, partly because the various factors for ulcer formation have a complicated relationship to the specificity of a disease, many anti-peptic ulcer agents do not have a satisfactory effect and safety.
For example, a histamine H.sub.2 receptor antagonist has a potent gastric acid excretion inhibiting activity, which brings about a rapid amelioration of a disease and shortens the therapy time, and is currently used as a first selected drug. Nevertheless, a problem exists in that this drug increases the rate of recurrence of the disease after therapy. The causes of this recurrence seem to be an acid rebound, a lowered defense factor, and a distortion of tissue after restoration based on the rapid therapy. Also, in the case of Cimetidine, adverse reactions such as abnormality of endocrine glands, for example, gynecomastia, and psychological disorder such as disorientation, have been reported. Furthermore, offense factor inhibitors, which lower the acidity in the stomach over a long term, are thought to cause a nitrosoamine synthesis through bacteria, and thus the possibility exists of a carcinogenicity caused thereby.
Offense factor inhibitors including proton pump inhibitors have been assessed as symptomatic treatment agents which are gastric acid secretion inhibitors.
On the other hand, defense factor potentiators may be considered as substantive treatment agents than offense factor inhibitors. The drugs which have been developed do not have a sufficient cytoprotection effect and a drug having a potent therapeutical activity cannot be found. Also, PG preparations now under development are reported to have adverse effects such as diarrhea, miscarriages, etc., because physiologically active substances are administered.
Therefore, under the present situation, it is difficult to treat a peptic ulcer with only a defense factor potentiator, and thus mainly a combined therapeutical method using the above histamine H.sub.2 receptor antanosist is employed.
In the internal treatment of ulcers, policies will change from a "quicker treatment" to a "cleaner treatment", from "a treatment of an ulcer during a disease" to a "prevention of a recurrence", and from "a uniform treatment" to an individual treatment corresponding to a specific disease".
Currently, the most desirable drug, from the viewpoint of the above trends, is a defense factor potentiator closer to the causative therapeutical method, but such a drug having a high effectiveness and low toxicity has not been found.
An object of the present invention is to provide a novel pharmaceutics having a cytoprotection effect providing a more substantial therapy.